Recruiting

Stereotactic Arrhythmia Radioablation

Sponsor:

University of Calgary

Code:

NCT04065802

Conditions

Stereotactic Radioablation for Ventricular Tachycardia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Radioablation

Study Details

Brief summary:

Stereotactic Arrhythmia Radioablation (STAR) ablation is a safe and feasible option for cardiomyopathy patients for management of refractory ventricular tachycardia.

STAR can be performed with available cardiac imaging, prior mapping/electrogram information, and standard ECGs without a multi-electrode ECG vest.

Conditions

Stereotactic Radioablation for Ventricular Tachycardia

Study ID

NCT04065802

Start date

Apr 14, 2021

Status verified date

Nov, 2022

Completion date

Dec 30, 2024

Anticipated

Primary completion date

Dec 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

18 years of age and have an implanted cardioverter defibrillator (ICD) with:

1. Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar.
2. At least one of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), and despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated):

A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means, DC cardioversion or manual ICD Therapy.

B: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours VT events must be confirmed by ECG/monitor or ICD download.

Exclusion Criteria:

  • Has received prior radiotherapy to the anticipated treatment field
  • Pregnancy
  • Unable to unwilling to provide informed consent
  • New York Heart Association class IV heart failure or inotrope use limiting the safe transport to the radiotherapy suite
  • Patients in whom the only ventricular arrhythmias are ventricular fibrillation, torsade de pointes, or polymorphic ventricular tachycardia.
  • Active coronary ischemia in the last 30 days.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radioablation Treatment

Patients will receive radioablation to scar regions of the heart responsible for ventricular tachycardia

Interventions

Stereotactic Radioablation

External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias

Primary outcome measure

  • Efficacy of radiation treatment for VT reduction [ Time Frame: 6 month period before treatment to the 6 month period after ablation with a 6 week blanking period post-treatment. ]
  • Safety composite endpoint of radiation treatment-related pericarditis, pneumonitis, changes in cardiac structures, function, and/or ICD function. [ Time Frame: 90 days after treatment ]

Central Contacts and Locations

Central contacts

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

More Information

Sponsor

University of Calgary

Last update posted

Nov 15, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-11-15.